title: A novel device for left atrial appendage exclusion: the third-generation atrial exclusion device.
abstract: OBJECTIVE
  Occlusion of the left atrial appendage is proposed to reduce the risk of stroke in patients with atrial fibrillation. The third-generation atrial exclusion device, modified to provide uniform distribution of pressure at appendage exclusion, was assessed for safety and effectiveness in a canine model and compared with a surgical stapler.
  
  
  METHODS
  The atrial exclusion device consists of 2 parallel, straight, rigid titanium tubes and 2 nitinol springs with a knit-braided polyester fabric. Fourteen mongrel dogs were implanted with the device at the base of the left atrial appendage via a median sternotomy. In each dog, the right atrial appendage was stapled with a commercial apparatus for comparison. The animals were evaluated at 7 days (n = 3), 30 days (n = 5), and 90 days (n = 6) after implantation by epicardial echocardiography, left atrial and coronary angiography, gross pathology, and histology.
  
  
  RESULTS
  Left atrial appendage exclusion was complete and achieved without hemodynamic instability, and coronary angiography revealed that the left circumflex artery was patent in all cases. A new endothelial tissue layer developed on the occluded orifice of the left atrium 90 days after implantation. This endothelial layer was not evident on the stapled right atrial appendage.
  
  
  CONCLUSIONS
  In dogs, the third-generation atrial exclusion device achieved easy, reliable, and safe exclusion of the left atrial appendage with favorable histologic results. Clinical application could provide a new therapeutic option for reducing the risk of stroke in patients with atrial fibrillation.
authors.affiliation: Department of Biomedical Engineering, Lerner Research Institute, Cleveland Clinic, Cleveland, Ohio 44195, USA.
authors.forename: Hideyuki
authors.initials: H
authors.lastname: Fumoto
authors.forename: A Marc
authors.initials: AM
authors.lastname: Gillinov
authors.forename: Yoshio
authors.initials: Y
authors.lastname: Ootaki
authors.forename: Masatoshi
authors.initials: M
authors.lastname: Akiyama
authors.forename: Diyar
authors.initials: D
authors.lastname: Saeed
authors.forename: Tetsuya
authors.initials: T
authors.lastname: Horai
authors.forename: Chiyo
authors.initials: C
authors.lastname: Ootaki
authors.forename: D Geoffrey
authors.initials: DG
authors.lastname: Vince
authors.forename: Zoran B
authors.initials: ZB
authors.lastname: Popović
authors.forename: Raymond
authors.initials: R
authors.lastname: Dessoffy
authors.forename: Alex
authors.initials: A
authors.lastname: Massiello
authors.forename: Jacquelyn
authors.initials: J
authors.lastname: Catanese
authors.forename: Kiyotaka
authors.initials: K
authors.lastname: Fukamachi
mesh_terms: D000704:Analysis of Variance; D000792:Angiography; D000818:Animals; D020517:Atrial Appendage / Q000473:pathology / Q000601:surgery*; D001281:Atrial Fibrillation / Q000517:prevention & control*; D004195:Disease Models, Animal; D004285:Dogs; D015150:Echocardiography, Doppler; D006439:Hemodynamics / Q000502:physiology; D007150:Immunohistochemistry; D020097:Natriuretic Peptide, Brain / Q000378:metabolism; D011336:Probability; D019736:Prostheses and Implants; D011474:Prosthesis Design; D019919:Prosthesis Implantation / Q000379:methods; D011897:Random Allocation; D012680:Sensitivity and Specificity; D020521:Stroke / Q000517:prevention & control*; D013525:Surgical Instruments
chemical_list: D020097:Natriuretic Peptide, Brain